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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00732654
Other study ID # NCT00014511
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received August 8, 2008
Last updated March 29, 2012
Start date August 2008
Est. completion date June 2015

Study information

Verified date March 2012
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date June 2015
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 21 Years
Eligibility Inclusion Criteria:

- Are age 6 to 21 years

- Provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable

- Have a history of symptomatic reactivity to cow's milk (i.e. Eczema, urticaria, upper or lower respiratory symptoms, GI disturbances, other rash or oral symptoms)

- Have a positive skin prick test (defined as wheal 3 mm = negative control) and cow's milk-IgE > 0.35 kIU/L

- Have a positive OFC to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein).

- Are using appropriate birth control if subject is female and of child bearing age.

- Have self-injectable epinephrine (ie. EpiPen® or EpiPen Jr.®) available at home

Exclusion Criteria:

- Have a history of severe anaphylaxis defined as hypoxia (cyanosis or SpO2 = 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence

- Have a history of intubation related to asthma

- Tolerate more than 184 milligrams of intact cow's milk protein at initial OFC

- Are pregnant or lactating

- Have a viral URI or gastroenteritis within 7 days of OFC (OFC needs to be rescheduled)

- Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma

- Are currently taking greater than medium dose inhaled corticosteroid (>400 mcg/day fluticasone or fluticasone equivalent if = 12 years old or > 600 mcg/day if > 12 years old)

- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges

- Have used systemic corticosteroids within 4 weeks prior to baseline visit

- Are receiving omalizumab, beta-blocker, ACE inhibitor or tricyclic antidepressant therapy

- Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)

- Have participated in any interventional study for treatment of a food allergy in the past 12 months

- Have a severe reaction at initial DBPCFC, defined as either:

Life-threatening anaphylaxis, or Reaction requiring hospitalization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Milk Protein Extract Immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy
Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Milk Powder Immunotherapy
Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Powder Immunotherapy
Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States Duke University Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Robert A. Wood Duke University, Greer Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is clinical response to treatment, defined as (1) tolerating ten times the initial oral food challenge threshold dose, OR (2) tolerating the maximum oral food challenge dose at the oral food challenge, at completion of immunotherapy. Approximately 1 1/2 years. No
Secondary The proportion of patients who maintain a clinical response after withdrawal of treatment for one week. Approximately 1 1/2 years. No
Secondary The proportion of patients who maintain a clinical response after withdrawal of treatment for six weeks. Approximately 1 1/2 years. No
Secondary Incidence of all serious adverse events during the study Approximately 1 1/2 years. Yes
Secondary Incidence of all adverse events during the study. Approximately 1 1/2 years. Yes
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